SuperHealthGuard and Loyal Great International Ltd. – FDA Warning Letter, Jun 29, 2020

On June 29, 2020, the FDA and FTC issued a Warning Letter to Superhealthguard.com, based in Mongkok, Hong Kong SAR, China, following website reviews on June 12 and June 23, 2020. The company was found to be selling "Lianhua Qingwen Capsule," a traditional Chinese medicine, in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act, and a misbranded drug under section 502. The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d). Examples of violative claims included assertions of effectiveness in COVID-19 patient recovery, inhibition of coronavirus, and reduction of severe cases.

The letter demanded immediate cessation of sales for these unapproved and unauthorized products. The company was required to email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply could result in legal action, including seizure and injunction. The firm would be added to FDA's public list of companies selling fraudulent COVID-19 products.

The FTC also cited violations of the FTC Act, stating that